eligibility_summary
Adults ≥18 with untreated AML (ICC 2022, excludes MDS/AML 10–19% blasts), unfit for intensive chemo (≥75 y ECOG 0–2 or 18–74 with significant comorbidities), adequate hepatic/renal function. Requires consent, contraception, controlled HIV allowed. Exclude: prior AML therapy (beyond cytoreduction), prior HMA/venetoclax for MDS/MPN, CNS leukemia, APL, poor ECOG, recent immunosuppression/live vaccine, active infection/malignancy, prior HSCT, HBV/HCV, severe cardiac disease, allergies, GI issues, major surgery <4 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, open-label, randomized trial in newly diagnosed AML patients ineligible for intensive therapy compares venetoclax+azacitidine+cusatuzumab vs venetoclax+azacitidine. Drugs and mechanisms: cusatuzumab (OV-1001) is a CD70-targeting monoclonal antibody that blocks CD70–CD27 signaling on AML blasts and leukemia stem cells and promotes immune-mediated killing (e.g., ADCC/CDC), venetoclax is an oral small-molecule BCL-2 inhibitor (BH3 mimetic) that restores mitochondrial apoptosis, azacitidine is a hypomethylating cytidine analog (DNA methyltransferase inhibitor) causing DNA hypomethylation and cytotoxicity. Targets: CD70+ AML blasts/LSCs and their immune signaling, intrinsic apoptosis pathway (BCL-2), and epigenetic dysregulation (DNA methylation) in myeloid cells.